{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,5]],"date-time":"2026-05-05T01:20:20Z","timestamp":1777944020707,"version":"3.51.4"},"reference-count":41,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2026,4,1]],"date-time":"2026-04-01T00:00:00Z","timestamp":1775001600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,4,1]],"date-time":"2026-04-01T00:00:00Z","timestamp":1775001600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/100004339","name":"Sanofi","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004339","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Regeneron Pharmaceuticals Inc."}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therap Adv Gastroenterol"],"published-print":{"date-parts":[[2026,4]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Dupilumab, a fully human monoclonal antibody that blocks interleukin-4 and -13 signaling, is approved for the treatment of eosinophilic esophagitis (EoE) based on phase III clinical trials. However, real-world data on dupilumab use for EoE are lacking.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives:<\/jats:title>\n                    <jats:p>To assess the characteristics, treatment patterns, and outcomes among patients with EoE aged 12\u2009years or older who receive treatment with dupilumab for EoE as prescribed under the US prescribing information.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design:<\/jats:title>\n                    <jats:p>This study protocol describes a phase IV, prospective, observational, multicenter patient registry, EDESIA, which will enroll approximately 300 patients aged 12\u2009years or older who initiate dupilumab treatment as part of routine care across approximately 50 sites in the USA.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis:<\/jats:title>\n                    <jats:p>Baseline data collection will include demographics, disease characteristics, medical history, and prior\/concomitant therapies. Data will be collected at baseline (day 1 of treatment) and at follow-up visits through 36\u2009months. Key primary outcomes assessed will include details of food elimination diet, history of food impaction and esophageal dilation, histologic and endoscopic findings, and patient-reported outcomes. Adverse events will be monitored throughout the study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics:<\/jats:title>\n                    <jats:p>The EDESIA registry will be conducted in accordance with the Declaration of Helsinki, the International Council for Harmonization guidelines for Good Clinical Practice, and applicable regulatory requirements. The local institutional review board at each study center will approve the study. Written informed consent will be obtained from all patients and\/or a parent\/legal guardian.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion:<\/jats:title>\n                    <jats:p>EDESIA will address the safety and tolerability of long-term weekly dupilumab treatment in patients with EoE, and inform future treatment guidelines.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration:<\/jats:title>\n                    <jats:p>\n                      A US registry of EoE adolescent and adult patients treated with DUPIXENT\u00ae as standard of care (EDESIA), NCT06693531 (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\/study\/NCT06693531\">https:\/\/www.clinicaltrials.gov\/study\/NCT06693531<\/jats:ext-link>\n                      ).\n        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USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mirna","family":"Chehade","sequence":"additional","affiliation":[{"name":"Mount Sinai Center for Eosinophilic Disorders, Icahn School of Medicine at Mount Sinai, New York, NY, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emily C.","family":"McGowan","sequence":"additional","affiliation":[{"name":"Division of Allergy and Immunology, Department of Medicine, University of Virginia, Charlottesville, VA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elizabeth T.","family":"Jensen","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology, Department of Medicine, Center for Esophageal Diseases and Swallowing, University of North Carolina School of Medicine, Chapel Hill, NC, USA"},{"name":"Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, Wake Forest University School of Medicine, Winston-Salem, NC, 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USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sabina","family":"deMarchi","sequence":"additional","affiliation":[{"name":"Regeneron Pharmaceuticals Inc., Tarrytown, NY, 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